Executive / Sr. Executive - Quality Control

SAVA Group; Surendranagar; On-site; INR 600,000 - 1,200,000; Full time

Job summary

SAVA Healthcare in India seeks a capable Executive / Sr. Executive - Quality Control to ensure quality and compliance of manufacturing processes and products through robust validation. You will drive IQ/OQ/PQ protocols, risk assessments, and documentation with cross-functional teams.

The role requires 3+ years in QC validation, strong analytical skills, and knowledge of GMP/FDA/EMA guidelines. Office-based with potential travel for audits and training.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 3 years of experience in QC validation within the pharmaceutical industry.
• In-depth knowledge of validation principles, GMP, FDA, EMA regulations, and industry standards.
• Proficiency in analytical techniques and instrumentation, such as HPLC, GC, spectroscopy, and microbiological methods.
• Strong experience in writing and reviewing technical documents.
• High level of accuracy and attention to detail.
• Excellent analytical and problem-solving skills.
• Strong verbal and written communication skills.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.

Responsibilities

• Develop and implement validation protocols (IQ/OQ/PQ) for equipment, systems, processes, and methods in the QC laboratory.
• Conduct validation studies, including risk assessments, to ensure compliance with regulatory requirements and company standards.
• Prepare and review validation documents, including protocols, reports, SOPs, and work instructions.
• Ensure all validation activities comply with GMP, FDA, EMA, and other relevant regulatory guidelines.
• Support internal and external audits by providing validation documentation and responding to audit findings related to QC validation.
• Identify opportunities for continuous improvement in validation processes and implement best practices.
• Train QC staff on validation procedures and ensure adherence to validation standards and practices.
• Work closely with QA, manufacturing, and R&D teams to ensure successful validation activities and integration of new products/processes into production.

Skills

Validation principles

GMP

FDA/EMA regulations

HPLC

Documentation

Attention to detail

Problem-solving

Communication

Teamwork

Education

Bachelor’s in Chemistry

Master’s in Pharmaceutical Sciences

Tools

HPLC

GC

Spectroscopy

Microbiological methods

Job description

Executive / Sr. Executive - Quality Control

2 to 8 Yrs.

Full-Time

Company: SAVA Healthcare is amongst the fastest emerging pharmaceutical company in India with global reach to customers in Canada, Ukraine and the CIS, Asia, Latin America, Africa & FWA. With manufacturing units in Surendranagar, Malur and in near future in Indore holds various accreditations and produces wide variety of dosage forms across therapeutic categories.

Our GMP compliant, State of Art manufacturing facility for Tablet, Oral Dry Powder, Capsule, Nasal sprays, DPIs, Cream, Gel and Ointment formulations with dedicated manufacturing sections supported by In-House R&D Center, focuses on Formulation and Analytical Development with an annual turnover of more than 200 crores and manpower of 500+ employees engaged across locations.

Job Summary:

This position will be responsible for ensuring the quality and compliance of our manufacturing processes and products through rigorous validation protocols. This role is pivotal in maintaining our commitment to producing safe and effective pharmaceuticals.

Key Responsibilities:

• Validation Protocol Development: Develop and implement validation protocols (IQ/OQ/PQ) for equipment, systems, processes, and methods in the QC laboratory.
• Execution of Validation Activities: Conduct validation studies, including risk assessments, to ensure compliance with regulatory requirements and company standards.
• Documentation: Prepare and review validation documents, including protocols, reports, standard operating procedures (SOPs), and work instructions.
• Compliance: Ensure all validation activities comply with GMP, FDA, EMA, and other relevant regulatory guidelines.
• Audit Support: Support internal and external audits by providing validation documentation and responding to audit findings related to QC validation.
• Continuous Improvement: Identify opportunities for continuous improvement in validation processes and implement best practices.
• Training: Train QC staff on validation procedures and ensure adherence to validation standards and practices.
• Cross-functional Collaboration: Work closely with QA, manufacturing, and R&D teams to ensure successful validation activities and integration of new products/processes into production.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Experience: Minimum of 3 years of experience in QC validation within the pharmaceutical industry.
• Knowledge: In-depth knowledge of validation principles, GMP, FDA, EMA regulations, and industry standards.
• Technical Skills: Proficiency in analytical techniques and instrumentation, such as HPLC, GC, spectroscopy, and microbiological methods.
• Documentation Skills: Strong experience in writing and reviewing technical documents.
• Attention to Detail: High level of accuracy and attention to detail.
• Problem-solving: Excellent analytical and problem-solving skills.
• Communication: Strong verbal and written communication skills.
• Teamwork: Ability to work effectively in a team environment and collaborate with cross-functional teams.

Preferred Qualifications:

• Certification in Quality Assurance or Validation from a recognized institution.
• Experience with statistical analysis and validation software.
• Familiarity with Lean Six Sigma methodologies.

Working Conditions:

• Primarily office-based with regular interaction in laboratory and manufacturing environments.
• May require occasional travel for audits, training, and conferences.